The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy

control

Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy

Procedure: Blood draw, 20ml peripheral blood mononuclear cells

One time blood draw of 20 ml

Detailed Description:

In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other

Criteria

Inclusion Criteria:

19 years of age or older, of either gender.

History of chronic hepatitis C as documented by HCVRNA.

. Documented genotype 1.

Subject prescribed antiviral therapy

Able to give informed consent.

Controls:

Greater than 19 years of age.

Subject reports good general health.

Subject denies chronic hepatitis C infection.

Able to give informed consent.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876174